Identity
- Trade Name
- L2 Two-Rack retinoscopy set – Plus and Minus EUDAMEDVisionix FDA UDI
- Generic Name
- Trial lens set FDA UDI
- Device Name
- Two-Rack retinoscopy set – Plus and Minus EUDAMEDSkiascopy racks FDA UDI
- Model / Reference
- L2 EUDAMED122084 EUDAMEDL2 Skiascopy racks FDA UDI
- Description
- Skiascopy racks FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000220 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000220LC EUDAMED
- FDA Product Code
- HMH FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Trial lens set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1750 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Trial lens set
Visionix by Luneau Technology Operations — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Trial lens set.
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- FRESNEL PRISM AND LENS — FRESNEL PRISM & LENS CO. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 55ee0ee3-63c9-4c1e-90b0-d04e6937c8d0 33 fields · synced Jul 9, 2026
- EUDAMED 31d6cc63-7d7b-478f-8320-77ae756c7211 61 fields · synced Jul 9, 2026